Luma Wrap Phototherapy Swaddler is designed to provide centered and comfortable boundaries as a b...
FDA Device Recall #Z-2181-2014 - Class II, July 11, 2014
Recall Summary
| Recall Number | Z-2181-2014 |
| Classification | Class II - Moderate risk |
| Date Initiated | July 11, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Beevers Manufacturing & Supply, Inc. |
| Location | McMinnville, OR |
| Product Type | Devices |
| Quantity | 240 total (112/ lot 66812; 92/ lot 66813; 17/ lot 30660; and 19/ lot 67879). |
Product Description
Luma Wrap Phototherapy Swaddler is designed to provide centered and comfortable boundaries as a benefit for restive babies in the Neonatal Intensive Care Unit.
Reason for Recall
Beevers Manufacturing & Supply Inc. is recalling Luma Wrap neonatal phototherapy blankets because the product was inadvertently misclassified and marketed without a cleared 510(k) submission from the US FDA.
Distribution Pattern
Product was distributed to US, Germany, Austria, France, Italy, Spain, Australia.
Lot / Code Information
Recalled units include: LW102 (medium), Lot 66812; LW103 (large), Lots 66813 and 30660; and LW105 (extra large), Lot 67879. LumaWrap models with an adhesive strip (LW102 and LW103) have a 2-year shelf life.
Other Recalls from Beevers Manufacturing & Supply, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0483-2015 | Class II | Cannulaide, Model 101, 102, 103. Respirator. ... | May 13, 2008 |
| Z-0487-2015 | Class II | Cannulaide, Model 101. The Cannulaide product i... | Jan 18, 2007 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic, removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.